CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Tolvaptandrug
Likely dose
Tolvaptan 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00413777
NCT00413777Phase 2Completed
CompareCT.gov

A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney Disease

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Dec 20, 2006·Updated Jul 2, 2017

In Brief

A Phase 2 clinical trial evaluating Tolvaptan for Polycystic Kidney, Autosomal Dominant. Completed, enrolled 46 participants across 11 sites.

Detailed Summary

This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Kidney, Autosomal Dominant
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2006
Enrollment StartDec 1, 2005
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.5 years ago

Interventions

Tolvaptandrug

Participants were titrated to either the tolvaptan 45/15 or 60/30 mg split-dose over a 2-month Titration Period. They received the titrated dose for 34 months during the Fixed-dose Period. Following a planned off-treatment period, participants had the option to enter an Extension Period for an additional 12 months. Tolvaptan was supplied as tablets.